# US 11,305,072 B2 · Tamper evident assembly for syringes

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,305,072 B2
- Document ID: US11305072B2
- Status: Granted
- Kind: B2
- Application number: 16/408,947
- Filed: 2019-05-10
- Published: 2020-05-28
- Granted: 2022-04-19
- Earliest claimed: 2018-11-28
- Assignees: Fresenius Kabi USA, LLC
- Applicants: Fresenius Kabi USA, LLC
- Inventors: Christopher J. Murray; Anthony Ferraro; Gang Ju; Robert Speek
- Web page: https://patentgrep.com/patent/US11305072B2

## CPC

- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 5/3134: {characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula}
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 2005/3104: {Caps for syringes without needle}
- A61M 2005/312: {comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting}
- A61M 2205/584: having a color code
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)

## Abstract

The present disclosure describes a syringe assembly including a syringe including a Luer connection and a tip, a plunger, a tip cap, a tamper evident cap disposed over the tip cap, and a film including a frangible connection. The film secures the tamper evident cap to the Luer connection, where the frangible connection can break under a force applied to the tamper evident cap such that the tamper evident cap disengages from the Luer connection when the frangible connection breaks.

## Claims

### Claim 1

A syringe assembly, comprising:
a syringe having a barrel body that extends from a proximal end to a distal end and defines a chamber extending along an axial direction therethrough, a luer connection at the distal end, and a tip extending from the distal end along the axial direction and defining an outlet in fluid communication with the chamber, wherein the chamber contains a material;
a plunger received within the chamber of the syringe to create a fluid seal within the barrel body;
a tip cap defining a central passage configured to receive a portion of the tip such that the tip cap creates a fluid seal over the outlet;
a tamper evident assembly, comprising:
a tamper evident cap disposed over the tip cap, wherein the tamper evident cap has a main body that defines a proximal end defining an opening, a closed distal end opposite the proximal end along the axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage extending from the opening of the proximal end configured to receive the tip cap; and
a film including a frangible connection and configured to secure the tamper evident cap to the luer connection,
wherein the frangible connection is configured to break under a force applied to the tamper evident cap such that the tamper evident cap is configured to disengage from the luer connection when the frangible connection breaks.

### Claim 2 (depends on 1)

The syringe assembly of claim 1, wherein the film is shrink-wrapped over a portion of the tamper evident cap and at least a portion of the luer connection.

### Claim 3 (depends on 1)

The syringe assembly of claim 1, wherein the film includes a color-coded portion that comprises a color selected from a plurality of colors that each correspond to a different material.

### Claim 4 (depends on 3)

The syringe assembly of claim 3, wherein the color of the color-coded portion corresponds to the material in accordance with ASTM D4774.

### Claim 5 (depends on 1)

The syringe assembly of claim 1, wherein the film is adhesive-bonded to the tamper evident cap.

### Claim 6 (depends on 1)

The syringe assembly of claim 1, wherein the film is adhesive-bonded to the luer connection.

### Claim 7 (depends on 1)

The syringe assembly of claim 1, wherein the tamper evident cap includes a plurality of ribs extending radially outwards from the outer surface and configured to secure the film to the tamper evident cap.

### Claim 8 (depends on 1)

The syringe assembly of claim 1, wherein the film is configured to engage the distal end of the syringe.

### Claim 9 (depends on 1)

The syringe assembly of claim 1, wherein the luer connection includes a plurality of ribs extending outwards from an outer surface and configured to secure the film to the luer connection.

### Claim 10 (depends on 1)

The syringe assembly of claim 1, wherein a portion of the main body defines a color-coded portion that comprises a color selected from a plurality of colors that each correspond to a different material.

### Claim 11 (depends on 1)

The syringe assembly of claim 1, wherein the tamper evident cap is spaced in an entirety from the syringe when the tamper evident cap engages the tip cap.

### Claim 12 (depends on 1)

The syringe assembly of claim 1, wherein a portion of the tamper evident cap is in contact with the tip cap.

### Claim 13 (depends on 12)

The syringe assembly of claim 12, wherein the fluid seal over the outlet is not compromised when the tamper evident cap is in contact with the tip cap or when the frangible connection is broken.

### Claim 14 (depends on 1)

The syringe assembly of claim 1, wherein the material includes an active ingredient that is (a) a therapeutic agent selected from a group consisting of anti-infectives, anesthetics, analgesics, anticoagulants, chemotherapeutics, hormones, antihypertensives, anti-inflammatories, antiemetics, bronchodilators, adrenergics, immunoglobulins, antipsychotics, and antidepressants or (b) a diagnostic agent selected from a group consisting of x-ray, MRI and ultrasound contrast agents, cholecystokinetics, and vasodilators.

### Claim 15 (depends on 1)

The syringe assembly of claim 1, wherein the material includes an active ingredient selected from a group consisting of an opioid, benzodiazepine, α2-adrenergic receptor agonist, beta blocker, morphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, codeine, buprenorphine, naloxone, naltrexone, fentanyl, remifentanil, sufentanil, alfentanil, meperidine, rocuronium, vecuronium, midazolam, lorazepam, diazepam, neostigmine, atropine, glycopyrrolate, dexmedetomidine, cisastracurium, ropivacaine, lidocaine, propofol, ketamine, succinylcholine, moxifloxacin, linezolid, levofloxacin, levetiracetam, vancomycin, cefepime, aztreonam, cefoxitin, ceftriaxone, cefazolin, cefotaxime, ceftazidime, gentamicin, oxacillin, nafcillin, penicillin, cefuroxime, ticarcillin, clavulanic acid, piperacillin, tazobactam, azithromycin, meropenem, ertapenem, tigecycline, micafungin, metronidazole, fluconazole, itraconazole, posaconazole, heparin, enoxaparin, dalteparin, theophylline, acetaminophen (paracetamol), ibuprofen, acetylcysteine, decitabine, azacitidine, docetaxel, pemetrexed, palonosetron, aprepitant, fosaprepitant, famotidine, amiodarone, nitroglycerin, nicardipine, clevidipine, dobutamine, esmolol, labetalol, metroprolol, somatropin, liraglutide, abaloparatide, semaglutide, teriparatide, degarelix, sumatriptan, epinephrine, ephedrine, vasopressin, methotrexate, testosterone, and hydroxyprogesterone.

### Claim 16

A method of filling a syringe with a material, the method comprising:
receiving a syringe having a barrel body extending from a distal end having a luer connection and a tip, wherein the tip defines an outlet having a tip cap placed thereon, to an open proximal end, the barrel body defining a chamber that extends along an axial direction therethrough;
filling the chamber with the material through the open proximal end;
placing a plunger at the open proximal end of the chamber;
placing, after placing the plunger at the open proximal end of the chamber, a tamper evident cap over the tip cap; and
attaching a film to the tamper evident cap and the luer connection such that the film secures the tamper evident cap to the luer connection.

### Claim 17 (depends on 16)

The method of claim 16, wherein attaching the film includes shrink-wrapping the film over the tamper evident cap and the luer connection.

### Claim 18 (depends on 16)

The method of claim 16, wherein attaching the film includes attaching the film to the syringe.

### Claim 19 (depends on 16)

The method of claim 16, wherein the film includes a color-coded portion that comprises a color selected from a plurality of colors that each correspond to a different material.

### Claim 20 (depends on 19)

The method of claim 19, wherein the color of the color-coded portion corresponds to the material in accordance with ASTM D4774.

### Claim 21 (depends on 16)

The method of claim 16, further comprising:
bonding the film to the luer connection via an adhesive.

### Claim 22 (depends on 16)

The method of claim 16, further comprising:
bonding the film to the tamper evident cap via an adhesive.

### Claim 23 (depends on 16)

The method of claim 16, wherein the film includes a frangible connection configured to break under a force applied to the tamper evident cap such that the tamper evident cap is configured to disengage from the luer connection when the frangible connection breaks.

### Claim 24

A tamper evident assembly, comprising:
a tamper evident cap having a main body that defines a proximal end defining an opening, a closed distal end opposite the proximal end along an axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage extending from the opening of the proximal end configured to receive a tip cap and a luer connection of a syringe; and
a film including a frangible connection and configured to secure the tamper evident cap to the luer connection, wherein the frangible connection is configured to break under a force applied to the tamper evident cap such that the tamper evident cap is configured to disengage from the luer connection when the frangible connection breaks.

### Claim 25 (depends on 24)

The tamper evident assembly of claim 24, wherein the frangible connection extends circumferentially around the tamper evident cap.